Data Collection
Quality by Design: Better data using participant insights
Quality is not an afterthought within clinical trials. Instead, it is a required and integral part of the entire process beginning at the start of protocol design. While clinical trials will always encounter challenges in driving quality experiences and data, there exists one approach that’s backed by regulatory agencies and proven to lead to better outcomes.
This is a “quality by design” strategy that’s informed and driven by all stakeholders, including those most affected by your trial’s protocols - your participants, and sites.
You asked we answered: How do eCOAs improve data compliance?
We at Medable are often asked in webinars, requests for proposals (RFPs), tradeshows, etc. just how exactly eCOAs and ePROs foster better patient compliance with submitting data.
Since you asked, our answer is below, courtesy of Jessica Dolfi, VP of Solution Consulting.
DCT Digital Week: Creating the Digital Foundation for Scale in Clinical Development
Learn how sponsors and CROs can improve their clinical trial conduct by developing new strategies that create sustainable, repeatable, and effective clinical conduct.
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
Back to basics: What are electronic clinical outcome assessments (COAs/eCOAs)?
COAs (called eCOAs when captured electronically) are essential to understanding whether a drug is reducing symptoms, improving patients’ quality of life, and improving patients’ ability to perform activities they care about. COAs enable a well-rounded understanding of how a drug is working, its side effects, its impact on patients’ lives, and more. Perhaps most notably, PROs/ePROs allow for the patient’s voice to be heard. Capturing the patient’s voice is particularly important because the clinician may not always see or express the patient’s experience in the same way.
Quality by design: How eCOA improves oversight and participant data quality
eCOA has the power to ease clinical research for all stakeholders. When developing and refining our eCOA offering, we consulted with our own Participant & Caregiver Network (PCN) to provide feedback on design. This allowed us to build our eCOA and the wider platform it fits within in a way that fosters better oversight, and better clinical trial data.
Why the future looks bright for eCOA in clinical trials
See why the electronic clinical outcome (eCOA) market is poised to continue its rapid growth and why Medable customers have chosen eCOA as a future foundation for their next era of clinical conduct.
Connecting in new ways: Our partnership with Withings Health Solutions
In June, Medable announced a partnership with Withings Health Solutions with the goal of reducing the burden on sponsors and sites while empowering patients to participate in trials from home.
What does the new European Medicine Regulatory Network recommendation paper on decentralized elements in clinical trials tell us?
Learn what impacts the new European Medicine Regulatory Network recommendations paper means to your clinical trial operations.
New EU Regulatory Recommendations for Decentralized Trials Keep Focus on Patients and Sites
As clinical trials rapidly modernize, government regulators work to evolve even as the same core principles apply. Still, decentralized clinical trials are – simply – clinical trials, as all research today is decentralized in some way, yet we lack global harmonization of regulations.
ePRO Case study: Better options and outcomes oncology trials.
Medable worked with a top 5 pharma company to increase the safety of patients as anti-cancer treatments may cause pulmonary toxicity, ranging from asymptomatic radiological changes to respiratory failure, and is considered a common side effect.
Actionable data: How to deploy & use patient-centric data collection to improve patient experiences & sharpen decision making
Medable's Gillian Livock, SVP/GM Digital Solutions and Sean Connelly, SVP, Product Management, join Antoine Pivron, Head of Health Solutions EMEA at Withings, to discuss the industry's move toward patient-first data collection, how to increase operational efficiencies, enhancing the patient experience in clinical trials using data, and how to use data insights to drive key decision-making.
Back to Basics: Remote patient monitoring
Remote patient monitoring programs and technologies are becoming increasingly popular, backed by growing clinical evidence showing numerous benefits to patients and providers. While remote patient monitoring (RPM) isn’t new, it’s evolving quickly due to the regulatory push to expand access to care during the COVID-19 pandemic. Coupled with the fact that the digital health market is poised to more than double by 2026, providers and patients have a greater ability to track vitals between visits, and both centralized and decentralized clinical trials rely on remote data collection now more than ever. While there is tremendous potential upside, some barriers and risks are inherent in this digital process. Human-centered design and strategic implementation can ensure that RPM in clinical trials is both beneficial and cost effective.